OxyNorm liquid

OxyNorm 5 mg/5 ml liquid

Oxycodone hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
  their symptoms are the same as yours.


• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
  please tell your doctor or pharmacist.

In this leaflet:

1. What OxyNorm liquid is and what it is used for

2. Before you take OxyNorm liquid

3. How to take OxyNorm liquid

4. Possible side effects

5. How to store OxyNorm liquid

6. Further information

What OxyNorm liquid is and what it is used for

This medicine has been prescribed for you by your doctor to relieve moderate to severe pain. It
contains the active ingredient oxycodone which belongs to a group of medicines called strong
analgesics or ‘painkillers’.

Before you take OxyNorm liquid

Do not take OxyNorm liquid if you:

• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the medicine (see section 6 ‘Further Information’);


• have breathing problems, such as chronic obstructive airways disease, chronic bronchial asthma or respiratory depression. Your doctor will have told you if you have any of these conditions.
  Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;


• have a head injury that causes a severe headache or makes you feel sick. This is because this
  medicine may make these symptoms worse or hide the extent of the head injury;


• have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;


• have a heart problem after long-term lung disease (cor pulmonale);


• have severe kidney problems or moderate to severe liver problems. If you have other long-term kidney or liver problems you should only take this medicine if recommended by your doctor;


• have ongoing problems with constipation;


• are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;


• are under 18 years of age.

Take special care with OxyNorm liquid

Before treatment with this medicine tell your doctor or pharmacist if you:

• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;


• have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;


• have low blood pressure (hypotension);


• have a mental disorder as a result of an infection (toxic psychosis);


• have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder;


• have inflammatory bowel disease;


• have prostate problems;


• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);


• have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;


• are or ever have been addicted to alcohol or drugs;


• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs.

If you are going to have an operation, please tell the doctor at the hospital that you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take this medicine with some other medicines, the effect of this medicine or the other medicine may be changed.

This medicine must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 “Do not take…”).

Tell your doctor or pharmacist if you are taking:

• medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);


• medicines to treat depression;


• medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);


• other strong analgesics or ‘painkillers’;


• muscle relaxants;


• medicines to treat high blood pressure;


• quinidine (a medicine to treat a fast heart beat);


• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);


• antifungal medicines (such as ketoconazole);


• antibiotics (such as erythromycin).

Also tell your doctor if you have recently been given an anaesthetic.

Taking OxyNorm liquid with alcohol

Drinking alcohol during your treatment with this medicine may make you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually more noticeable when you first start taking this medicine, or when changing to a higher dose. If you are affected you should not drive or use machinery.

How to take OxyNorm liquid

Always take this medicine exactly as your doctor has told you. The label on your medicine will tell you how much to take and how often.

Adults (over 18 years of age)

The usual starting dose is 5 ml every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor.

Children

Children and adolescents under 18 years of age should not take the medicine.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

You must only take this medicine by mouth. This medicine should never be injected as this may lead to serious side effects, which may be fatal.

If you take more OxyNorm liquid than you should or if someone accidentally swallows your
medicine

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining medicine with you to show to the doctor.

If you forget to take OxyNorm liquid

If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking OxyNorm liquid

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

OxyNorm liquid Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).

As with all strong painkillers, there is a risk that you may become addicted or reliant on this medicine.

Common side effects

(Probably affecting more than 1 in 100 people taking this medicine)

• Constipation (your doctor can prescribe a laxative to overcome this problem).


• Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).


• Drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days).


• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.


• Headache, confusion, a feeling of unusual weakness, dizziness, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams.


• Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.


• Rash, itchy skin.


• Sweating, chills.

Uncommon side effects

(Probably affecting fewer than 1 in 100 people taking this medicine)

• Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders (e.g. upset stomach), changes in taste.


• A feeling of dizziness or ‘spinning’, a feeling of ‘faintness’ especially on standing up, hallucinations, mood changes, depression, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, shaking, difficulties with speech, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred vision.


• Difficulty in passing urine, impotence, decreased sexual drive, absence of menstrual periods.


• Fast, irregular heart beat, low blood pressure, flushing of the skin.


• Dehydration, thirst, swelling of the hands, ankles or feet.


• Dry skin, severe flaking or peeling of the skin.


• Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature.


• A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).

Uncommonly, this medicine may affect the results of blood tests to check that your liver is working properly.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store OxyNorm liquid

Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.

Do not use this medicine after the expiry date which is stated on the label and carton. EXP 08 2010 means that you should not take any of this medicine after the last day of that month i.e. August 2010.

Do not store your medicine above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What OxyNorm liquid contains

The active ingredient is oxycodone hydrochloride. Each 5 ml contains 5 mg of oxycodone hydrochloride.

The other ingredients are:

• Saccharin sodium


• Sodium benzoate


• Citric acid


• Sodium citrate


• Hydrochloric acid


• Sodium hydroxide


• Purified water


• Hypromellose

What OxyNorm liquid looks like and contents of the pack

This medicine is a clear colourless/straw-coloured solution.

Each bottle contains 250 ml of liquid.

Marketing Authorisation Holder and Manufacturer

This medicine is made by Bard Pharmaceuticals Limited for the marketing authorisation holder

Napp Pharmaceuticals Limited

both at Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: OxyNorm liquid

Reference number: 16950/0003

This leaflet was last revised in May 2009.

OxyNorm
and the NAPP device (logo) are Registered Trade Marks.

© 2009 Napp Pharmaceuticals Ltd

P0058-A R2V3 UK AW 10-02-09